Saliva-based Detection of CD44

NCT03148665 | Completed DMC FDA Device

• 1 other identifier: 161215
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to test the ability of OncAlert™ to screen for cancer and the reappearance of cancer. OncAlert™ was developed by Vigilant Biosciences, a collaborator in this research study. OncAlert™ is an oral rinse which is spit into a cup and sent to a laboratory for analysis. OncAlert™ is considered experimental by the FDA because it is not approved for the screening of cancer.

Conditions

Oral Cavity Squamous Cell Carcinoma; Oropharynx Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Head and Neck

Keywords

Oral Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• To validate performance of the Vigilant Oral Rinse Point of Care strip in a multi-institutional clinical setting

  * The agreement between CD44 ELISA and BCA test as measured using the POC test (OncAlert) and central laboratory testing at Vigilant The concordance of these two measures will be assessed using Cohen's kappa statistic for a dichotomized outcome (positive vs. negative test). A kappa of 0.6 or lower will be considered of insufficient concordance, and the minimum required level indicating adequate concordance is a kappa of 0.8 * The sensitivity and specificity of the OncAlert test to detect OOPSCC in cases compared to a non cancer control population. * A specificity of 0.65 minimally acceptable for the Vigilant POC test. In order to demonstrate a clinically acceptable level of specificity, a performance goal of 0.75 is chosen

  4 years

Secondary Outcomes (2)

• To prospectively validate the performance of pretreatment Vigilant Oral Rinse Point of Care strip and Sol CD44 as a predictor of outcome for oral/oropharyngeal cancer in a point of care multi-institutional clinical setting

  4 years

• To determine the association of post treatment salivary solCD44 and the Vigilant Oral Rinse Point of Care strip with disease outcome in oral/oropharyngeal cancer

  4 years

Study Arms (2)

Control population

Control population (n=150): absence of current or prior oropharyngeal carcinoma, no active cancer diagnosis. Control population includes at least 50 subjects who have smoked at least 100 cigarettes during lifetime OncAlert saliva-based screening, a noninvasive point of care salivary rinse test performed as a one-time test for control subjects

Device: OncAlert

Cancer population

Cancer population (n=150): patients with previously untreated oral cavity or oropharynx squamous cell carcinoma with absence of distant metastasis OncAlert saliva-based screening, a noninvasive point of care salivary rinse test performed as at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients

Device: OncAlert

Interventions

OncAlert DEVICE

A noninvasive point of care salivary rinse test performed as 1) a one-time test for control subjects, 2) at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients

Cancer population; Control population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients were identified through tumor board. Control patients were identified by referral.

You may qualify if:

• Patient has the ability to understand and the willingness to sign a written informed consent.
• Previously untreated, measurable squamous cell carcinoma of the oral cavity or oropharynx with no evidence of distant metastasis, T1-4N0-3M0
• No prior history of treated upper aerodigestive tract cancer
• No concurrent, second, active malignancy other than oral cavity and/or oropharynx cancer
• Planned to undergo treatment with curative intent
• Able to follow up after therapy at 3, 6, 12, and 18 months after completion of therapy during routine post treatment follow up
• For control subjects: no evidence or history of upper aerodigestive tract cancer
• For control subjects: absence of any suspected or confirmed active malignancy at time of enrollment
• Patients may have had prior therapy for malignancy other than upper aerodigestive malignancy completed 2 years prior to enrollment if they have been disease free since completion of therapy
• Patient is ≥ 18 years of age.
• Both men and women of all races and ethnic groups are eligible for this trial.
• Performance Status ≤ ECOG 3
• Patient is able to gargle and spit 5 cc of saline
• Patients may be concurrently enrolled in other therapeutic or detection clinical trials

You may not qualify if:

• Prior completed therapy for an upper aerodigestive tract cancer within the past 3 years.
• Patient unable to gargle and spit 5 cc of saline, or anticipated to be unable to gargle and spit after completion of therapy
• Patient unable or does not intend to undergo curative therapy
• Patient with concurrent, second primary malignancy under active therapy or completed therapy within 2 years prior to enrollment.

Sponsors & Collaborators

• Joseph Califano: lead
• Vigilant Biosciences, Inc.: collaborator
• Greater Baltimore Medical Center: collaborator
• San Diego Veterans Healthcare System: collaborator
• NYU Langone Health: collaborator
• Johns Hopkins University: collaborator

Study Sites (4)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21231, United States

Location

New York University College of Dentistry

New York, New York, 10010, United States

Location

Related Publications (1)

• Franzmann EJ, Qi Y, Peifer S, Messer K, Messing B, Blanco RG, Khan Z, Fahkry C, Coffey C, Califano J 3rd. Salivary CD44 and Total Protein Levels to Detect Risk for Oral and Oropharyngeal Cancer Recurrence: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Oct 1;150(10):843-850. doi: 10.1001/jamaoto.2024.2490.

  PMID: 39145961 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Joseph Califano, MD

  University of California, San Diego

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Chair

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: April 14, 2017
• Primary Completion: April 10, 2019
• Study Completion: May 3, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)